MAUDE Adverse Event Report: MEDIVATORS INC ADVANTAGE PLUS PASS THRU ENDOSCOPE REPROCESSING SYSTEM

Model Number ADVPT3008

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2024

Event Type  malfunction  

Event Description

The user facility reported that water was leaking from their advantage plus pass thru endoscope reprocessing system into the floor below.No report of injury.

Manufacturer Narrative

A steris service technician inspected the advantage plus pass thru endoscope reprocessing system and found that the drain hose was out of alignment.The technician stated that the drain hose looked like it had been moved from its location subsequently causing water to splash out of the drain box and out onto the floor.During the steris technician's discussion with user facility personnel, it was stated that a user facility employee could have moved the drain hose prior to the reported event.The steris technician reinstalled the drain hose, tested the function and operation of the unit and returned it to service.The steris technician counseled user facility personnel on the importance of not moving the drain hose and to contact steris should the unit require service activity.No additional issues have been reported.

• Brand Name: ADVANTAGE PLUS PASS THRU ENDOSCOPE REPROCESSING SYSTEM
• Type of Device: ENDOSCOPE REPROCESSING SYSTEM
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 14605 28th ave north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 18990170
• MDR Text Key: 338772850
• Report Number: 2150060-2024-00023
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964095832
• UDI-Public: 00677964095832
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVPT3008
• Device Catalogue Number: ADVPT3008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1